Cap displacement mechanism for lancing device and multi-lancet cartridge

ABSTRACT

A medical lancing device including a replaceable multi-lancet cartridge. The lancing device includes an advancing mechanism that advances lancets within the cartridge into an active position, separates a protective cap from the active lancet, and energize a drive mechanism of the lancing device. A cap displacement mechanism moves the separated cap out of the travel path of the active lancet. In a first example embodiment, the cap displacement mechanism includes a cantilevered spring arm that displaces the detached cap of the active lancet. In a second example embodiment, the cap displacement mechanism includes a spring-biased cam-driven plunger that displaces the detached cap of the active lancet. Then an activation mechanism releases the energized active lancet to traverse the unobstructed lancing stroke path to pierce the subject&#39;s skin at a desired lancing site.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the priority benefit of U.S. Provisional PatentApplication Ser. No. 60/562,712, filed Apr. 16, 2004, which is herebyincorporated herein by reference in its entirety.

TECHNICAL FIELD

The present invention relates generally to medical devices andprocedures and, more particularly to cartridge assemblies for lancingdevices for the collection and/or analysis of samples of blood or otherbodily fluids.

BACKGROUND OF THE INVENTION

Many medical procedures require puncturing of the skin, and sometimesunderlying tissues, of an animal or human subject. For example, a sharplancet tip is commonly used to puncture the subject's skin at a lancingsite to obtain a sample of blood, interstitial fluid, or other bodyfluid, as for example in blood glucose monitoring by diabetics and inblood typing and screening applications.

In some instances, a person must periodically sample their blood formultiple testing throughout the day or week. Because re-use of a lancetcan result in infection or spread of blood-borne contaminants, personsrequiring repeated testing often must carry around multiple lancets thatare separately loaded into a lancing device for each sampling. This canbe inconvenient and may lead to reduced compliance with a prescribedtest regimen.

Accordingly, it has been discovered that needs exist for an improvedlancing device capable of carrying out multiple sampling procedureswithout the need for separately loading individual lancets. It has alsobeen discovered that needs exist for a convenient, disposablemulti-lancet cartridge that can be loaded into a multi-use lancingdevice for carrying out multiple sampling procedures, and then beremoved and replaced when fully or partially spent or when replacementis otherwise desired. It is to the provision of an improved samplingdevice and cartridge meeting these and other needs that the presentinvention is primarily directed.

SUMMARY OF THE INVENTION

Briefly described, in one aspect, the present invention is a lancingdevice comprising an outer housing for receiving a replaceablecartridge. Preferably, the cartridge includes a static outer shell thatremains stationary relative to the housing and drive mechanism of thelancing device, and an array of lancets that are rotationally advancedwithin the outer shell and sequentially indexed through an activeposition for carrying out multiple lancing procedures. The cartridgepreferably includes a rotationally moveable carrier for retaining androtationally advancing the radial array of lancets within the outershell, and for constraining the active lancet along a controlled andpre-defined path of travel during the lancing stroke. The cartridgepreferably also includes recesses, clips or other retainers forretaining protective endcaps that have been removed from the lancets outof the path of travel of the lancets, and preventing the caps fromrattling around within the housing.

The lancing device preferably includes a drive mechanism, including forexample a pair of opposed biasing mechanisms (e.g., springs) working intandem, to drive and return the plunger mechanism of the lancing deviceand propel the active lancet through its lancing stroke. In exampleembodiments, the jaw of the drive mechanism engages the active lancetfrom the bottom only, through a slot in the cartridge shell, so that apartially spent cartridge can be removed from the lancing device andreinserted for use at a later time. In further example embodiments, thelancing device includes a one-way clutch or ratchet mechanism to advancelancets sequentially through the active position and to prevent re-useof lancets. The lancing device preferably also includes an advancing andcharging mechanism for sequentially indexing the lancet carrier,charging the drive mechanism, and detaching the endcap of the lancet ata controlled retraction rate during de-capping, all with a single andcontinuous operation.

The lancing device optionally includes a depth ring for adjusting thedepth of penetration of the lancet. Preferably, the depth ring has aplurality of openings with varying opening sizes and varying countersinkdepths, and is rotatable through a sequence of positions adjacent thelancet opening in the housing of the lancing device, thereby forming arotating shutter window, providing a wide range of depth control. Infurther example embodiments, the lancing device includes an improvedactivating button operable to activate the drive mechanism, andincluding an integral spring arm for biasing the activating buttonoutwardly and a retainer for securing the rotating depth ring.

In another aspect, the invention is an improved cartridge assembly foruse with a multi-use lancing device. The cartridge assembly preferablyincludes a plurality of penetration elements or lancets, each having itsown protective covering or endcap, arranged for sequential use inpiercing the skin or other tissue of a human or animal subject forobtaining a sample of blood, interstitial fluid, and/or other bodyfluid(s). In example embodiments, the cartridge has an outer shell orhousing and a carrier assembly rotationally enclosed within the outershell for retaining the lancets. Because the carrier rotationallyadvances the lancets within the outer shell of the cartridge, only oneopening through the shell is required for allowing passage of the activelancet tip upon actuation of the device, thereby reducing the potentialfor contamination or accidental needle sticks.

And in yet another aspect, the present invention is a cap displacementmechanism that moves a sterility cap, after it has been separated fromthe active lancet, out of the lancing stroke travel path of the activelancet. In a first example embodiment, the cartridge includes acantilevered spring arm that is mounted within the cartridge shell tobias the separated lancet cap out of the path of the lancing stroke. Ina second example embodiment, the lancing device includes a spring-biasedplunger that is driven along a cam surface of the lancing device toengage a lancet cap and push it transversely out of the path of thelancing stroke. In both embodiments, the carrier defines transverseguide paths near its outer perimeter for directing and retaining thelancet caps out of the travel path of the lancet tip. The transverseguide paths are preferably defined by one or more guide tracks (e.g.,resilient fingers, barbs, or other engagement features) extending fromthe carrier for positively retaining the lancet caps that have beenremoved from the lancet bodies.

These and other aspects, features and advantages of the invention willbe understood with reference to the drawing figures and detaileddescription herein, and will be realized by means of the variouselements and combinations particularly pointed out in the appendedclaims. It is to be understood that both the foregoing generaldescription and the following brief description of the drawings anddetailed description of the invention are exemplary and explanatory ofpreferred embodiments of the invention, and are not restrictive of theinvention, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a multi-lancet cartridge assembly for alancing device in accordance with a first example embodiment of thepresent invention.

FIG. 2 is an exploded perspective view of the cartridge assembly of FIG.1, showing a base housing, lancet array, carrier disk, spring-arm capdisplacer, and cover housing.

FIG. 3 is a cutaway perspective view of the lancet array, carrier, andspring arm of FIG. 2, showing spring arm displacing a separated cap ofan active lancet.

FIG. 4 is a perspective view of a cartridge assembly for a lancingdevice in accordance with a second example embodiment of the presentinvention.

FIG. 5 is an exploded perspective view of the cartridge assembly of FIG.4, showing a base housing, lancet array, carrier disk, and coverhousing.

FIG. 6 is a partial perspective view of an advancer mechanism of thelancing device for use with the cartridge of FIG. 4, showing aspring-loaded cap-displacing plunger driven by a cam surface of theadvancer mechanism.

FIG. 7 is a perspective view of a lancing device according to the secondexample embodiment of the invention, suited for use with the cartridgeassembly of FIG. 4, showing the lancing device in an opened positionrevealing the advancer mechanism of FIG. 6 situated therein, and showingthe spring-loaded cam-driven plunger extending through the upper shellof the advancer mechanism.

FIG. 8 is a partial cutaway perspective view of the advancer mechanismof FIG. 6, showing the spring-biased cam-driven plunger displacing a capof an active-position lancet.

FIG. 9 is a side view of the advancer mechanism of FIG. 6, showing thespring-biased cam-driven plunger reset to a position clear of thelancing stroke travel path.

FIG. 10 is another exploded perspective view of the cartridge assemblyof FIG. 4.

FIG. 11 is a bottom view of the cartridge assembly of FIG. 10 with thebottom cover removed for clarity.

FIG. 12 is a perspective view of a drive and return mechanism of thelancing device of FIG. 7.

FIG. 13 is a perspective view of a lancing depth adjustment ring of thelancing device of FIG. 7.

FIG. 14 is a top view of an actuator button portion of the lancingdevice of FIG. 7.

FIG. 15 a is a detailed plan view of a portion of the advancer mechanismof FIG. 6 located on the bottom of the housing of the lancing device ofFIG. 7.

FIG. 15 b is a detailed plan view of the advancer mechanism of FIG. 6,including the portion shown in FIG. 15 a.

FIG. 16 is a perspective view of the cartridge of FIG. 4 installed inthe lancing device of FIG. 7.

DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS

The present invention may be understood more readily by reference to thefollowing detailed description of the invention taken in connection withthe accompanying drawing figures, which form a part of this disclosure.It is to be understood that this invention is not limited to thespecific devices, methods, conditions or parameters described and/orshown herein, and that the terminology used herein is for the purpose ofdescribing particular embodiments by way of example only and is notintended to be limiting of the claimed invention. Also, as used in thespecification including the appended claims, the singular forms “a,”“an,” and “the” include the plural, and reference to a particularnumerical value includes at least that particular value, unless thecontext clearly dictates otherwise. Ranges may be expressed herein asfrom “about” or “approximately” one particular value and/or to “about”or “approximately” another particular value. When such a range isexpressed, another embodiment includes from the one particular valueand/or to the other particular value. Similarly, when values areexpressed as approximations, by use of the antecedent “about,” it willbe understood that the particular value forms another embodiment.

In its various embodiments, the present invention provides a lancet capdisplacement mechanism that moves a cap, after it has been separatedfrom an active lancet, out of the lancing stroke travel path of theactive lancet. In a first example embodiment, the cap displacementmechanism is embodied in a replaceable multi-lancet cartridge for use incombination with a multi-use lancing device. In a second exampleembodiment, the cap displacement mechanism is embodied in a multi-uselancing device for use in combination with an improved replaceablemulti-lancet cartridge.

The improvements of the present invention are adaptable for applicationin connection with various forms of multi-lancet lancing devices. Inparticular, the improvements of the present invention are of potentialapplication to the multi-lancet lancing devices and replaceablemulti-lancet cartridges shown in PCT International Publication No. WO03/071940 A1 (International Application No. PCT/US03/05159, filed Feb.20, 2003), which is hereby incorporated herein by reference. It will berecognized that the improvements disclosed herein are of individualadvantage, or can be used in combination with one another.

In general, the lancing device of the present invention comprises ahousing defining a chamber for receiving the cartridge; a drivemechanism for propelling an active lancet of the cartridge through alancing stroke, from a retracted position within the cartridge to anadvanced position wherein a sharp tip of the active lancet projectsthrough a lancet opening in the housing to pierce the subject's skin atan intended lancing site; a charging mechanism for energizing the drivemechanism; and an advancing mechanism for sequentially advancing lancetsof the cartridge into and through the active position. Various of thesemechanisms can be combined; for example, a single mechanism optionallyserves to energize the drive mechanism and simultaneously orsequentially advance the cartridge.

It will be understood that the lancet cap displacement mechanisms of thepresent invention may be embodied in a variety of styles of lancetcartridges and lancing devices. For example, the cap displacementmechanisms can be adapted for use in a cartridge having a radial arraysof lancets (as described herein), a linear array of lancets, acylindrical array of axially arranged lancets, or other lancet andcarrier configurations. And the cap displacement mechanisms can beadapted for use in disposable multi-lancet lancing devices (without areplaceable cartridge), with the components of the cap displacementmechanisms being elements of the lancing devices.

1. The Cartridge Assembly

With reference now to the drawing figures, FIGS. 1 and 2, as aperspective and exploded view respectively, show a cartridge assemblyaccording to a first example embodiment of the present invention, whichas a whole is designated by the reference number 10. The cartridgeassembly 10 comprises a housing 12 for an array of lancets 20. Thehousing 12 preferably has two portions that connect together, forexample, a top portion or cover 14 and a bottom portion or base 16. Thetop portion 14 and the bottom portion 16 preferably comprise generallycircular disk-like structures with generally circular central alignedopenings. The bottom portion 16 preferably has guides thereon or thereinfor engaging and guiding a rotatable carrier disk 18. When secured totogether, the top portion 14 and the bottom portion 16 collectively forman annular outer shell of the cartridge assembly 10 for containing thecarrier 18 and the array of lancets 20. In addition, the top cover 14preferably defines a single lancet opening 15 on its outercircumferential rim, through which the tip of an active one of thelancets 20 passes during its lancing stroke.

The carrier disk 18 preferably includes guide channels 19 for permittingradial sliding movement of the lancets 20 in a lancing stroke between aretracted position and an extended position during the lancingoperation. The guide channels 19 may be formed by projections on orrecesses in the face of the carrier disk 18. In an example embodiment,the carrier 18 comprises twenty radial guide channels 19 for holdingtwenty lancets 20. The carrier 18 may, however, be provided with more orless guide channels 19 and lancets 20, as desired.

The lancets 20 are radially arranged in the rotatable carrier disk 18 inthe guide channels 19, and can be driven through their lancing strokesin their axial direction (i.e., along a radius of the carrier disk 18)upon actuation of the lancing device. The cartridge assembly 10 isarranged such that the carrier disk 18, loaded with the lancets 20, isrotatably mounted on the bottom portion 16 of the housing 12. The topportion 14 of the housing 12 is then secured to the bottom portion 16,for example by ultrasonic welding, such that the carrier disk 18 and thelancets 20 can rotate within the housing 12. A one-way clutch or ratchetmechanism preferably limits the rotation of the carrier disk to rotationin a single direction to prevent re-use of a lancet and resultantpotential contamination.

Referring additionally to FIG. 3, the lancets 20 each preferablycomprise a needle or blade forming a sharp lancet tip 22, and a lancetbody 24, and are preferably arranged generally radially in the guidechannels 19 of the carrier disk 18 with their tips 22 directedoutwardly. Preferably, the lancet body 24 is formed of plastic and isinjection-molded around the lancet tip 22. Each lancet tip 22 ispreferably encapsulated by a protective endcap 28, which may beintegrally molded with the lancet body 24 and forms a sterility andsafety barrier for the lancet tip.

The protective cap 28 of each lancet 20 is preferably connected to thebody 24 by one or more thin segments or a reduced-thickness transitionregion such as a notch or slit, which forms a weaker separation zonethat gives easily so that the cap can be removed. When the lancingdevice is charged or cocked (i.e., when the plunger of the drivemechanism pulls the lancet body 24 radially inwardly to energize thedrive mechanism), the separation zone 30 fails and allows the protectivecap 28 to easily detach from the lancet body 24. Alternatively, forlancets having caps that are discrete structures, the separation zone isdefined by the gap between the cap and the lancet body.

Each lancet body 24 has a retainer that engages a cooperating structureof the lancing device's drive mechanism (described below) when thelancet is in the active position. For example, each lancet body 24 mayhave a retainer foot 26 extending downward from the back of the lancetbody 24 to engage a cooperating jaw or other structure of the drivemechanism's reciprocating plunger when the lancet is in the activeposition. The feet 26 of the lancets 20 that are not in the activeposition preferably slide within a curved foot channel in the cartridgebottom housing 16 to constrain the used lancets against movement in theradial direction unless the lancet is in the active position.

The cartridge bottom housing 16 preferably defines a radial lancingchannel 17 extending from the curved foot channel at a positioncorresponding to the lancet opening 15 in the cartridge top housing 14.The active lancet slides in the lancing channel 17 as it is driven alongthe lancing stroke upon activation or firing of the lancing device.

One or more cap surfaces 29 are engaged and constrained by cooperatingcap guide tracks 31 of the carrier 18. The cap surfaces 29 may bedefined by two shoulders projecting laterally outwardly on oppositesides of the cap 28, as shown, or by other features such as recessesformed into the caps. The cap guide tracks 31 hold unused lancets 20 inposition on the carrier 18 prior to use, and to hold the cap 28 as theactive lancet body 24 is retracted upon charging or energizing of thedrive mechanism to detach the cap. The cap guide tracks 31 preferablydefine a transverse guide path (i.e., out of the plane of the lancetarray, preferably at about 90 degrees relative to the lancing stroketravel path) along which the cap 28 is moved after it is detached fromthe lancet body 24. This transverse guide path allows removal of the cap28 from the path of travel of the active lancet 20 as it is driventhrough its lancing stroke upon activation. The cap guide tracks 31preferably comprise one or more resilient fingers or barbs for guidingthe detached cap 28 along the transverse guide path and retaining thecap in its transversely displaced position so that it is prevented fromrattling around within the housing 12 or potentially interfering withthe device's operation. As an example, four cap guide track fingers 31may be provided for receiving and guiding the two cap shoulder surfaces29, as shown. Alternatively, two cap guide track fingers may be providedfor guiding and being received by two cap recessed surfaces.

As shown in FIGS. 1 and 3, the carrier disk 18 can optionally be labeledwith numbers or other indicia to indicate the number of unused lancets20 remaining (or alternatively the number of lancets already used). Thecartridge housing 12 preferably has an opening 40 therethrough, and thelancing device has a corresponding opening, such that the user can viewthe indicia.

The cartridge 10 preferably has a resilient member that is biased intoengagement with an underlying lancet 20 in the active position. Theresilient member thus prevents said active lancet 20 from beingdisplaced if the cartridge 10 is removed from the lancing device afterthe device is charged and the cap is detached, at which point the activelancet would otherwise be unconstrained. The resilient member preferablycomprises a resilient tongue portion 41 formed by a pair of cutout slotsdefined in the top housing cover 14 of the cartridge 10. When thecartridge 10 is installed in the lancing device, a cooperating portionof the drive mechanism flexes the tongue 41 out of contact with theactive lancet, freeing it to traverse its lancing stroke upon actuationof the lancing device. In an alternate embodiment, the carrier ispartially indexed within the cartridge housing (for example, a half-stepforward or back, to a position between adjacent lancets), when thecartridge is removed from the lancing device, to prevent displacement ofan unconstrained lancet from the active position.

a. Spring-Actuated Displacement of End-Caps

In this first example embodiment, the lancet cap displacement mechanismis provided by a cantilevered spring member 50 that serves to press thedetached protective cap 28 of each sequential active lancet 20 along thetransverse guide path and out of the radial path of travel of thatlancet prior to activation or firing. The spring member 50 preferablyhas a first section 52, a second section 54, and an intermediate section56. The first section 52 is attached (by conventional fasteningstructures or techniques) to the inner surface of the top portion 14 ofthe housing 12, or to another stationary part of the cartridge 10. Thesecond section 54 is configured to engage the protective cap 28 and topush the cap 28 downwardly along the cap guide tracks 31 of the carrier18, towards the bottom portion 16 of the housing 12. The intermediatesection 56 connects the first section 52 to the second section 54.

In a typical commercial embodiment, the spring member 50 is leafspring-type spring member, comprising a flexible, resilient piece ofmetal or other material that does not readily take on a set permanentdeformation. The first section 52, the second section 54, and theintermediate section 56 each include an elongated member. And theintermediate section 56 is angled or curved downwardly from the firstsection 52 to the second section 54, thereby offsetting the first andsecond sections. In this way, the spring member 50 rides along the topsurface of a lancet's endcap 28 as that lancet is advanced into theactive position, and the spring member 50 flexes upwardly and is chargedto impart a downward force on the cap. Then upon detachment of the cap28 from the active lancet 20 by the retraction of the lancet body 24,the cap is pressed down along the guide tracks 31 under the influence ofthe charged spring member 50.

In an alternative embodiment, the leaf spring-type spring member 50 isinverted and attached to the housing bottom 16. In another alternativeembodiment, the member 50 is a coil spring, with one end (the firstsection 52) attached to the housing 12 and the other end (the secondsection 54) including a ramped extension panel for riding along the capsas they are rotated to the active position.

b. Cam-Actuated Displacement of End-Caps

Referring now to FIGS. 4-9, a second example embodiment of the presentinvention will be described. The cartridge assembly 100 is substantiallysimilar to the cartridge assembly 10 described above, having a housing112 with top and bottom sections 114 and 116, a carrier 118, and anarray of lancets 120 each having a body 124 and a cap 28.

In this embodiment, however, the lancet cap displacement mechanism isprovided by a spring-biased cam-driven plunger assembly. This assemblyincludes a plunger 232 that is positioned at about the cartridge outerperimeter and adjacent (beneath or above) the active lancet position.The plunger 232 is the form of a pin, shaft, tube, T-member, anglepiece, or other elongated structure. With particular reference to FIGS.6 and 9, the plunger 232 is ordinarily biased away from the activelancet (e.g., downwardly) under the influence of a spring element 233.The spring element 233 may be provided by a cantilevered leaf spring armthat is attached to (and integrally formed with) the plunger 232, asshown. Alternatively, the spring element may be provided by a coilspring (e.g., coaxially arranged with the plunger), an elastic member(e.g., rubber band), or other biasing structure. In the depictedembodiment, the plunger 232 extends through an opening 235 in the uppershell 237 of the advancing mechanism 230, and the spring element 233 isattached to the upper shell and the plunger.

The spring-biased cam-driven plunger assembly further comprises a camsurface 234 formed, for example, on the lower shell 239 of the advancermechanism 230 of the lancing device. Preferably, the cam surface 234 isgenerally wedge-shaped, as shown, with two of the wedges arranged atabout 180 degrees apart, though other specific shapes, numbers, andspacings of the cams may be used. As the advancer mechanism 230 isactuated, a follower surface of the plunger 232 traverses along the camsurface 234. The plunger 232 rises as it moves along the upwardlyinclined portion of the cam surface 234, at the same time charging thespring arm 233. As the plunger 232 rises, it is pressed into engagementwith the cap 128 of the active lancet 120. The rising plunger 232 pushesthe cap 128 upwardly along the cap guide tracks 131 of the carrier disk118 along the transverse guide path at about 90 degrees relative to thelancing stroke travel path, and out of the radial path of the activelancet's lancing stroke. The cap guide tracks 131 are preferablyresilient members (e.g., barbs or fingers) that retain the cap 128 abovethe path of travel of the active lancet, as seen best with reference toFIG. 8. Continued actuation of the advancer mechanism 230 moves theinclined portion of the cam surface 234 past the plunger 232, as seenbest with reference to FIG. 9, allowing the plunger to drop back downunder the influence of the charged spring arm 233. The plunger 232 isnow reset and out of the active lancet's path of travel as it ispropelled along its lancing stroke.

It will be understood that the spring-biased, cam-driven plungerassembly may be provided as part of one or more other components of thelancing device. For example, in an alternative embodiment the spring andplunger are attached to and extend upwardly from the housing bottom withthe spring biased upwardly to displace the lancet caps. And the camsurface is formed on a rotary element (e.g., rotationally moved by theadvancing mechanism) within the lancing device housing. The cam surfacemay be configured to drive the plunger downwardly away from the activelancet cap except when the lancet is charged and ready for activation,at which position the plunger moves under the influence of the spring todisplace the cap. For example, the cam surface may be defined by two (oranother number of) upwardly recessed notches that permit the plunger tomove upward to displace the caps. In other alternative embodiments, thecam surface is defined on a stationary element and the plunger isrotated relative to the cam surface for driving the plunger to displacethe lancet caps.

2. The Lancing Device

As shown in FIG. 16, a lancing device 200 according to an exampleembodiment of the present invention preferably comprises a clam-shellhousing 202 having a top portion 204 hingedly connected to a bottomportion 206. The housing 202 defines a lancing opening 208, preferablythrough a sidewall portion 210 thereof, that aligns with the lancingopening 15 of an installed cartridge 100. The housing 202 preferablyalso comprises a latch 216 that secures the top 204 of the housing 202to its bottom 206.

The lancing device preferably further comprises a drive mechanism, seenbest with reference to FIGS. 7, 12, and 16. The drive mechanismpreferably includes a reciprocating plunger 250 that engages the activelancet 20 and drives it radially along its lancing stroke uponactivation or firing of the device, through an advanced position wherethe lancet tip punctures the subject's skin, and back to a retractedposition where the lancet tip is shielded within the cartridge. Theplunger 250 preferably comprises a recess forming a jaw 256 forreceiving and engaging the foot 26 of the active lancet. In a preferredembodiment, two springs, a drive spring 252 and a return spring 254,operate in tandem to drive and return the plunger 250 upon activation ofthe lancing device by pressing the activating button 220. The springscan be, for example, coil springs, leaf springs, torsion springs, spiralsprings, or the like, including other biasing mechanisms. The drivespring 252 is the stronger of the two springs, and drives the activelancet from its initial position into its extended position. The returnspring 254 serves to retract the active lancet after lancing the skin.One or more limit members, such as posts or lugs optionally interactwith one or both springs, and/or with other portion(s) of the drivemechanism, to more precisely define the equilibrium, retracted, and/orextended position(s) of the plunger. Because the jaw 256 of the plungeris open to the top, it securely but releasably engages the foot 26 ofthe active lancet to drive the lancet along its lancing stroke, yetallows the cartridge to be removed and replaced at any point during itsuse. The plunger 250 preferably further comprises a flexible release arm253 having a catch portion 255 that retains the plunger in its armedstate, with drive spring 252 energized prior to activation, and isreleased by the activating button upon actuation to propel the activelancet through its lancing stroke.

The lancing device preferably further comprises a mechanism for depthcontrol, in one embodiment a depth-control ring 212, shown in detail byFIG. 13. The depth ring 212 is positioned near the perimeter of thehousing 202 of the lancing device 204, and generally follows the contourof the housing of the lancing device 200. The depth ring 212 defines aplurality of openings 214A, 214B . . . 214N (collectively, the “openings214”) therethrough, through which the tip of a lancet 20 is driven topierce a skin surface of the subject to obtain a sample of blood. Theopenings 214 vary in diameter and/or in the depth to which their outercontact surfaces are recessed or countersunk. The depth ring 212 isrotated by the user to selectively position a particular opening 214 inalignment with the puncture position 208, thereby controlling the depthof penetration of the lancet tip into the subject's skin. Because theopenings can vary in diameter and in recess depth, the depth ring 212provides a wide range of depth control. The travel of the lancet 20preferably is not affected by variation of the position of the depthring 212, and so the lancing stroke preferably remains uniformregardless of the depth control position.

The lancing device preferably further comprises an activating buttonpositioned on the top half-shell 204 of the housing 202 for activatingthe drive mechanism to propel the active lancet through its lancingstroke. An example configuration of the activating button member 220 isshown in FIG. 14. The activating button member 220 preferably includes abutton portion 222, which releases the catch portion 255 of the plungerrelease arm when pressed by the user to activate or fire the device. Theactivating button member 220 preferably further comprises one or moreintegral spring arms 224 for biasing the button 222 outwardly. Theactivating button member 220 preferably further comprises a retainerring for securing the depth control ring 212 in place.

The lancing device 200 preferably further comprises an advancermechanism 230 as seen best with reference to FIGS. 8, 9, 15 a, 15 b, and16. In preferred form, the advancer mechanism 230 generally comprises amanually-rotatable element that is operable to advance the carrier tomove sequential lancets 20 of a lancet cartridge 118 into the activeposition. A finger preferably projects from the advancer mechanism 230through a slot in the bottom housing of the lancet cartridge to engageand advance the lancet carrier through indexed rotational incrementscorresponding to one lancet position, while the outer housing of thelancet cartridge remains fixed in position. Actuation of the advancermechanism 230 preferably also functions to engage the active lancet inthe jaw of the plunger and retract the plunger to de-cap the activelancet and energize or arm the drive mechanism.

Actuation of the advancer mechanism 230 may also serve to drive thespring-biased cam-driven plunger 232, as described above, ifimplementing the second example embodiment. Preferably, the advancermechanism 230 is operable to rotate in one direction only and indiscrete increments (e.g., 180° increments). Guide channels or ribs 231formed in or on the inner face of the advancer mechanism act as campaths to engage a cooperating follower element of the drive mechanism toretract the drive plunger 250 into its armed state, with drive spring252 energized. Preferably, the guide channels or ribs 231 are contouredto retract the plunger 250 more slowly at the beginning of the advancingstroke, while the endcap 28 is being detached from the lancet, providingmechanical advantage for smoother and easier operation. A ratchetmechanism 234 may be provided to prevent reverse rotation of theadvancer mechanism. Optionally, at the end of the advancing operation, alocating pin is driven upwardly (as by a cam surface similar to themotion of plunger 232 described above) through an opening in thecartridge housing and engaged within a yoke 122 (see FIGS. 10 and 11)between lancet paths on the carrier disk 118, to more precisely positionthe active lancet and prevent further movement of the carrier disk untilthe lancing device is fired.

In further preferred embodiments, the carrier 118 comprises a groove 124that engages a pin on the bottom portion of the housing of the cartridgeassembly when all the lancets have been used. This groove and pincombination prevents the cartridge 100 from being moved in eitherdirection after all of the lancets have been used, and thereby prevent areuse of a non-sterile lancet.

Method of Operation

In operation, the user preferably releases a latch 216 to open thelancing device 200. The user then places a preassembled multi-lancetcartridge 100 into the lancing device 200 and closes and latches thehousing 202. The user turns the advancer mechanism 230 through a 180°stroke. During the 180° rotation, the carrier 118 is indexed by onelancet position, thus indexing an unused lancet 20 into the activeposition. The plunger 250 engages foot 26 of the lancet and pulls thelancet radially inwardly. This step energizes the drive spring of thedrive mechanism. The catch 255 of the plunger engages a cooperatingsurface feature of the housing, and the lancet is now in the energizedor armed position.

As the lancet 20 is retracted radially inward to charge the drivespring, the cap 28 is held and prevented from moving radially inwardwith the lancet by the guide track (e.g., detents, fingers, or barbs)119. In this way, the lancet cap 28 is separated from the lancet body24. Then the cap displacement mechanism then moves the disengaged capout of the travel path of the active lancet. In the first exampleembodiment, the spring arm 50 engages and moves the detached cap 28 outof the lancing stroke path where the cap is held by the guide track, andthen the spring element returns to its reset or rest position clear ofthe lancing stroke. In the second example embodiment, the spring-biasedcam-driven plunger 232 engages and moves the detached cap 28 out of thepath of travel of the active lancet, then clears the cam and is biasedback to its rest or reset position. The guide track (e.g., detents,fingers, or barbs) 119 capture the cap 28 and hold it above the path thelancet 20 will travel in the lancing stroke.

The user may adjust the depth ring 212 to the desired setting to varythe penetration depth. If present, the position lock pin is raised intoengagement with the yoke 122 of the cartridge 118 to prevent furthermovement of the cartridge until activated or fired to release the activelancet to traverse its lancing stroke.

The lancing device 200 is positioned against a finger or other part ofthe subject's body. The activation button 220 is pressed, releasing thecatch 255 of the plunger and allowing the drive spring 252 to drive theplunger 250 and the active lancet engaged in the jaw thereof along acontrolled radial path, through an extended position where the lancettip punctures the subject's skin at the lancing site. The lancet ispreferably guided throughout its lancing stroke along three sides by theguide channels of the carrier 118 and on the fourth side by thecartridge housing. Upon reaching the extended position of the lancingstroke, the return spring 254 is energized to bias the plunger 250 andretract the lancet inwardly to a retracted position within the lancetcartridge.

While the invention has been described with reference to preferred andexample embodiments, it will be understood by those skilled in the artthat a variety of modifications, additions and deletions are within thescope of the invention, as defined by the following claims.

1-11. (canceled)
 12. A lancing device for use with a cartridge having anarray of lancets, each lancet including a detachable cap, the lancingdevice comprising: an advancing mechanism adapted to sequentiallyadvance the lancets into an active lancet position; a drive mechanismhaving a drive member adapted to engage and retract an active-positionedone of the lancets to detach the corresponding active-positioned cap,and to drive the active-positioned lancet along a lancing stroke; and acap-displacement mechanism including a spring-biased cam-driven plungeradapted to engage and move the active-positioned and detached lancet capfrom the lancing stroke path of the active-positioned lancet.
 13. Thelancing device of claim 12, further comprising a spring element thatbiases the plunger relative to the cap of the active-positioned lancet.14. The lancing device of claim 13, wherein the spring element biasesthe plunger away from the cap of the active-positioned lancet.
 15. Thelancing device of claim 13, further comprising a cam surface that drivesthe plunger against the bias of the spring element and moves the plungerrelative to the cap of the active-positioned lancet.
 16. The lancingdevice of claim 13, wherein the plunger has a follower surface thattranscribes the cam surface to drive the plunger upon movement of thecam surface relative to the plunger.
 17. The lancing device of claim 13,wherein the spring element biases the plunger away from the cap of theactive-positioned lancet, and further comprising a cam surface thatdrives the plunger against the bias of the spring element and intoengagement with the cap of the active-positioned lancet to displace theactive-positioned and detached lancet cap from the lancing stroke pathof the active-positioned lancet.
 18. The lancing device of claim 12,wherein the cap-displacement mechanism is operably coupled to theadvancing mechanism so that the operation of the advancing mechanismalso operates the cap-displacement mechanism.
 19. The lancing device ofclaim 12, further comprising a housing containing the advancingmechanism, the drive mechanism, and the cap-displacement mechanism,wherein the multi-lancet cartridge is replaceably received in thehousing, wherein the plunger is extendible out through an opening in thelancing device housing and in through an opening in the cartridge toengage the cap of the active-positioned lancet.
 20. The lancing deviceof claim 12 in combination with the multi-lancet cartridge of claim 12.21. The lancing device of claim 12, a plurality of guide tracks definingan array of transverse guide paths along which the lancet caps aredisplaced transversely from the lancing stroke path, and wherein theguide tracks are adapted to retain the lancet caps after displacementfrom the lancing stroke path.
 22. A lancing device for use with acartridge having an array of lancets, each lancet including a detachablecap, the lancing device comprising: an advancing mechanism adapted tosequentially advance the lancets into an active lancet position; a drivemechanism having a drive member adapted to engage and retract anactive-positioned one of the lancets to detach the correspondingactive-positioned cap, and to drive the active-positioned lancet along alancing stroke; and a cap-displacement mechanism including a plungerwith a follower surface, a spring element that biases the plunger awayfrom the cap of the active-positioned lancet, and a cam surface, whereinthe follower surface transcribes the cam surface upon movement of thecam surface relative to the plunger to drive the plunger against thebias of the spring element and into engagement with the cap of theactive-positioned lancet to displace the active-positioned and detachedlancet cap from the lancing stroke path of the active-positioned lancet.23. The lancing device of claim 22, wherein the spring element comprisesa cantilevered leaf spring.
 24. The lancing device of claim 23, whereinthe cantilevered leaf spring extends from the plunger.
 25. The lancingdevice of claim 22, wherein the follower surface transcribes the camsurface upon rotary movement of the cam surface relative to the plunger.26. The lancing device of claim 22, wherein the cam surface includes aplurality of ramped segments that drive the plunger as the plungerfollower surface transcribes the ramped segments.
 27. The lancing deviceof claim 22, wherein the cap-displacement mechanism is operably coupledto the advancing mechanism so that the operation of the advancingmechanism also operates the cap-displacement mechanism.
 28. The lancingdevice of claim 22 in combination with the multi-lancet cartridgeassembly of claim
 22. 29. The lancing device of claim 22, a plurality ofguide tracks defining an array of transverse guide paths along which thelancet caps are displaced transversely from the lancing stroke path, andwherein the guide tracks are adapted to retain the lancet caps afterdisplacement from the lancing stroke path.
 30. The cartridge assembly ofclaim 29, wherein the lancet caps define one or more cap guide surfacesthat engage and ride along the guide tracks as the caps are displacedfrom the lancing stroke path.
 31. The cartridge assembly of claim 30,wherein the guide tracks engage the cap guide surfaces to retain theactive-positioned cap from being retracted with the active-positionedlancet so that the retained active-positioned cap separates from theretracted active-positioned lancet.